Evaluating Procedure-Specific Bariatric Supplements on Micronutrient Levels and Vitamin B6 Balance After Metabolic and Bariatric Surgery

What this Trial Is About

Obesity is a complex chronic disease affecting over 650 million adults worldwide and is linked to many health problems including metabolic, cardiovascular, and musculoskeletal conditions. Metabolic and Bariatric Surgery MBS is an effective long-term treatment for obesity, supporting sustained weight loss and remission of related diseases. However, MBS causes changes in digestion and nutrient absorption, leading to risks of vitamin imbalances, especially vitamin B6 deficiency or excess, which can cause nerve problems. This trial studies three specialized Elan bariatric supplements designed with a consistent, low dose of vitamin B6 400 micrograms daily tailored for patients undergoing one of three MBS types sleeve gastrectomy SG, Roux-en-Y gastric bypass RYGB, or one-anastomosis gastric bypass OAGB. Participants will receive the supplement matching their surgery type to compare vitamin B6 levels and overall micronutrient status. The study aims to identify risks of vitamin B6 toxicity or deficiency and assess supplement adherence and changes in body measurements. Participants will be monitored at 6 and 12 months after surgery with blood tests measuring vitamin B6 and other nutrients, body measurements, and adherence questionnaires. Researchers will evaluate the prevalence of vitamin B6 imbalance, related micronutrient deficiencies, and links between supplement use and clinical outcomes. The study lasts 12 months postoperatively, providing insights to improve vitamin supplementation safety after bariatric surgery.

A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery